V-18™ Control Wire™ M001468520Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 08714729070191), received between Dec 11, 2018 and Sep 17, 2026 — classified as 12 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810491 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810327 ↗
• InjuryDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT MEDWATCH (B)(4) DEVICE FRACTURE OCCURRED REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE LUNG. A 200CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, A WIRE COMPONENT FROM THE INTRAVASCULAR EQUIPMENT WAS FRACTURED AND MIGRATED FROM THE VEIN TO THE PULMONARY REGION TO THE LUNG. IMAGING CONFIRMS IT LOCATION AND WAS SUCCESSFULLY RETRIEVED. THIS EXTENDED THE PROCEDURE AND RESULTED IN ADDITIONAL FLUOROSCOPIC EXPOSURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693562 ↗
• MalfunctionNov 17, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21OCT2025. IT WAS REPORTED THAT DEVICE KINK OCCURRED. THE 50-60% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 200CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS KINKED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED DISTAL TIP DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576247 ↗
• MalfunctionNov 12, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. DURING A PERIPHERAL INTERVENTION PROCEDURE, THE TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED, MODERATELY TORTUOUS, APPROXIMATELY 50% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA). DESPITE THE CALCIFIED LESION AT THE SFA, THE PHYSICIAN SUCCESSFULLY CROSSED THE LESION USING THIS V-18, 200 CM POLY TIP CONTROL WIRE AND PERFORMED ANGIOPLASTY WITH A 5.0 X 220 MM X 90 CM STERLING BALLOON. THEN A 5.0 X 200 MM X 90 CM RANGER DRUG COATED BALLOON WAS USED TO TREAT THE POPLITEAL TO MID SFA, FOLLOWED BY A 5.0 X 100 MM X 80 CM RANGER DRUG COATED BALLOON TO TREAT THE MID TO PROXIMAL SFA. THE 5.0 X 100 MM X 80 CM RANGER BALLOON WAS INFLATED TO A NOMINAL PRESSURE OF 6 ATMOSPHERES, AND DURING DEFLATION, THE BALLOON DID NOT DEFLATE COMPLETELY. THE PHYSICIAN ATTEMPTED FOR APPROXIMATELY 10 TO 15 MINUTES TO DEFLATE THE BALLOON USING AN ENCORE 26 INDEFLATOR DEVICE, BUT THIS WAS UNSUCCESSFUL. ADDITIONAL ATTEMPTS WERE MADE TO RETRACT THE BALLOON NEAR THE SHEATH AT THE COMMON FEMORAL ARTERY AND PRICK THE BALLOON UNDER ULTRASOUND GUIDANCE; HOWEVER, THIS WAS ALSO UNSUCCESSFUL. THE BALLOON REMAINED PARTIALLY INFLATED AND COULD NOT BE WITHDRAWN THROUGH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537101 ↗
• MalfunctionNov 10, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN 8CM, 200CM V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS INSERTED INTO THE CATHETER, IT WAS INTERRUPTED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511655 ↗
• MalfunctionOct 24, 2025Fracture; Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem; Fracture; Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A 200CM, 8CM V-18 GUIDEWIRE WAS SELECTED FOR ANGIOPLASTY. HOWEVER, BASED ON THE PHOTO PROVIDED BY THE ACCOUNT, THE HYDROPHILIC COATING OF THE GUIDEWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380371 ↗
• MalfunctionJan 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE TIP BROKE. A 200CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, HOWEVER, IT WAS NOTED THAT THE TIP OF THE WIRE BROKE OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161135 ↗
• InjuryOct 11, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED, CAUSING PERFORATION AND THE PLACEMENT OF A COVERED STENT. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT PERONEAL ARTERY. AN OPTICROSS 18 IMAGING CATHETER AND A 200CM, 8CM V-18 CONTROL WIRE WERE SELECTED FOR ARTERIAL INTERVENTION. DURING THE PROCEDURE, THE CATHETER BECAME TWISTED AND ENTANGLED WITH THE WIRE, RESULTING IN WIRE TIP DETACHMENT. THE PHYSICIAN COULD NOT REMOVE THE CATHETER FROM THE WIRE, SO BOTH WERE TAKEN OUT TOGETHER. CONSEQUENTLY, CONTRAST LEAKING WAS NOTED DISTAL TO THE CATHETER, BELIEVING THAT THE WIRE'S MOVEMENT MIGHT HAVE CAUSED A PERFORATION IN THE PERONEAL ARTERY. AS A RESULT, A COVERED STENT WAS PLACED IN THE AREA OF CONCERN. THE DEVICES WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT FULLY RECOVERED POST-PROCEDURE.

  Patient problems: Extravasation; Perforation

  MAUDE report 20433229 ↗
• InjuryAug 23, 2024Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE WIRE COATING WAS DETACHED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED PULMONARY ARTERY. A 200CM, 8CM POLY TIP V-18 CONTROL WIRE WAS ADVANCED INTO THE LESION, BUT IT WAS UNSUCCESSFUL. A NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO SUPPORT THE WIRE. AFTER SEVERAL MANIPULATIONS, AN OPAQUE OBJECT WAS OBSERVED UNDER FLUOROSCOPY. IT APPEARED TO BE A PIECE OF THE COVERED POLYMER OR A FRAGMENT OF THE SEVERED WIRE. THE DETACHED WIRE COATING WAS ATTEMPTED TO BE RETRIEVED USING A SNARE, BUT IT WAS UNSUCCESSFUL. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS ADVANCED BUT FAILED TO CROSS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT'S CONDITION AT THE END OF THE PROCEDURE WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20052101 ↗
• MalfunctionMay 24, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE WAS STUCK IN THE CATHETER. A 2X40X90 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION ALONG WITH A 200CM, 8CM V18 CONTROL GUIDEWIRE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AND DEFLATED SUCCESSFULLY. UPON REMOVAL OF THE BALLOON, IT WAS NOT ABLE TO BE REMOVED FROM THE WIRE. THE PHYSICIAN TRIED TO PULL IT BACK GENTLY OVER THE WIRE, BUT IT DID NOT RESOLVE THE ISSUE. SUBSEQUENTLY, BOTH THE BALLOON AND THE GUIDEWIRE WERE TAKEN OUT TOGETHER FROM THE PATIENT, AND SUCCESSFULLY MANAGED TO REMOVE THE WIRE FROM THE BALLOON SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER V-18 WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391294 ↗
• MalfunctionMar 20, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-FEB-2024. IT WAS REPORTED THAT A WIRE KINK OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 200CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USED. DURING THE PROCEDURE, A KINKED IN THE WIRE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A COATING WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943583 ↗
• MalfunctionFeb 14, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE STUCK OCCURRED. A 200CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE BECOME STUCK WITH THE 5X60MM NON-BOSTON SCIENTIFIC BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705402 ↗
• MalfunctionSep 29, 2023Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. A V-18 200CM, 8CM CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE HAD BECOME INCREASINGLY DIFFICULT TO ADVANCE. THE WIRE WAS PULLED OUT OBSERVED THAT THE ENTIRE EIGHT CENTIMETERS OF THE WIRE COATING WAS OFF. ALL OF THE WIRE COATING WAS ABLE TO BE REMOVED FROM THE PATIENT, AND A NEW V-18 CONTROL WIRE WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843193 ↗
• MalfunctionSep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. A V-18, 200CM, 8CM POLY TIP CONTROL WIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE WIRE BROKE OFF IN THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756624 ↗
• MalfunctionJun 15, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN AN ARTIFICIAL ENDOVASCULAR SHUNT ANASTOMOSIS IN A MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 200CM, 8CM POLY TIP V-18 CONTROL WIRE AND A NON-BOSTON SCIENTIFIC BALLOON CATHETER WERE USED. HOWEVER, DURING THE PROCEDURE, THE WIRE GOT STUCK AND STOPPED WORKING. THE ENTIRE BALLOON WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139502 ↗
• MalfunctionJun 12, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE DISTAL TIP DETACHED. A V-18 CONTROL WIRE WAS SELECTED FOR USE IN RECANALIZATION PROCEDURE OF THE ANTERIOR TIBIAL ARTERY. DURING THE RECANALIZATION, RESISTANCE WAS NOTED WHEN RETRACTING THE V-18 CONTROL WIRE INTO THE BALLOON CATHETER. WHILE WITHDRAWING BOTH THE BALLOON AND V-18 CONTROL WIRE, THE DISTAL TIP OF THE V-18 CONTROL WIRE DETACHED BUT REMAINED INSIDE THE BALLOON CATHETER. BOTH DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17111080 ↗
• MalfunctionFeb 6, 2023Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT ON THE DEVICE. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SHUNT VESSEL. A 200CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE TOGETHER WITH A NON-BOSTON SCIENTIFIC (BSC) BALLOON CATHETER. HOWEVER, A SIGNIFICANT RESISTANCE WAS FELT WHEN THE TIP OF THE WIRE CROSSED THE STENT IN FRONT OF THE CENTRAL LESION. AN ECHOCARDIOGRAM CONFIRMED THAT IT PROBABLY DID NOT PASS THROUGH THE STENT STRUT. IT HAS BEEN A WHILE SINCE THE STENT WAS PLACED, SO THE INTIMA SHOULD BE STRETCHED. AFTER THE GUIDE WIRE DID NOT ADVANCE IN THE BODY AND THE TORQUE WAS NO LONGER EFFECTIVE, IT WAS TAKEN OUT OF THE BODY AND THE GUIDE WIRE WAS ADVANCED AND PULLED IN THE GUIDE WIRE LUMEN OF THE BALLOON TO CHECK THE CONDITION, AND A FOREIGN OBJECT THAT WAS ABOUT 1 CM BLACK THAT IS THINNER THAN THE GUIDE WIRE CAME OUT. ACCORDING TO THE PHYSICIAN, THE DAMAGE TO THE GUIDEWIRE WAS NOT VISUALLY CONFIRMED. THE FOREIGN MATTER SEEMED TO BE PART OF THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308618 ↗
• InjuryDec 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A LOWER LIMB, BELOW THE KNEE ANGIOPLASTY. A 200CM, 8CM POLY TIP V-18 CONTROL WIRE GUIDE WIRE WAS ADVANCED; HOWEVER, DURING THE PROCEDURE, THE TIP OF THE WIRE WAS BROKEN INSIDE PATIENT. THE DETACHED TIP WAS REMOVED USING A STENT TO TRAP IT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15946158 ↗
• MalfunctionDec 1, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 200CM, 8CM V-18 CONTROL WIRE GUIDEWIRE WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP WAS BENT ALONG WITH THE ENTIRE MICRO CATHETER, AND IT COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893022 ↗
• MalfunctionNov 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 200CM, 8CM V-18 CONTROL WIRE WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE TIP WAS BROKE INSIDE THE PATIENT. THE DEVICE WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15806729 ↗
• InjuryNov 10, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT HYDROPHILIC COATING ISSUE OCCURRED. A 200CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING PROCEDURE, THE PHYSICIAN NOTICED THERE WAS A BLACK IMAGE IN THE DUCTUS AND THOUGHT IT WAS CONTRAST. HOWEVER, WHEN PULLING OUT THE GUIDEWIRE, THE PHYSICIAN NOTICED THAT A PIECE OF THE HYDROPHILIC COATING WAS COMPLETELY MISSING, JUST 2 CM BELOW THE TIP. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15771957 ↗
• MalfunctionJul 14, 2022Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 200CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE. HOWEVER, UPON PREPARATION, IT WAS NOTICED THAT THERE WAS A SMALL TEAR IN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15015284 ↗
• MalfunctionJul 23, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE MORE THAN 50% STENOSED TARGET LESION WAS LOCATED IN THE LOWER LIMB ARTERY BELOW THE KNEE. AFTER A 200CM, 8CM V-18 CONTROL WIRE WAS USED TO CROSS THE LESION, A 3.0MM X 150MM X 90CM STERLING SL BALLOON CATHETER WAS ADVANCED FOR DILATATION. UPON REMOVAL OF THE BALLOON, IT WAS NOTED THAT THE BALLOON NOT ABLE TO SLIDE OVER THE GUIDEWIRE AND THE WIRE WAS STUCK INSIDE THE BALLOON SHAFT. BOTH DEVICES WERE PULLED-OUT OF THE SHEATH AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218597 ↗
• InjuryJul 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS BUT CALCIFIED SUPERFICIAL FEMORAL ARTERY AND INFRA-POPLITEAL ARTERY. A 200CM, 8CM POLY TIP V-18 CONTROL WIRE WAS ADVANCED FOR NAVIGATING AND DELIVERY. HOWEVER, UPON CHECKING FINAL ANGIOGRAPHY, IT WAS OBSERVED THAT THE WIRE BLACK POLYMER DISTAL TIP WAS TOTALLY SEPARATED ABOUT 3CM INTO THE PATIENT BODY. THE DETACHED TIP WAS REMOVED FROM THE PATIENT BODY THROUGH SNARING DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12212141 ↗